Manual SDTM mapping is a critical bottleneck, consuming hundreds of programmer hours per study and delaying submissions. This custom agentic workflow automates the interpretation of Case Report Form (CRF) annotations and the application of CDISC standards. By deploying rule-based and LLM-assisted agents, it transforms raw EDC and lab data into audit-ready SDTM domains—such as DM, AE, and LB—with embedded define.xml metadata, reducing dataset creation time by 60-80% while improving data quality for regulatory review.




